You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 22, 2024

Details for Patent: 8,778,394


✉ Email this page to a colleague

« Back to Dashboard


Which drugs does patent 8,778,394 protect, and when does it expire?

Patent 8,778,394 protects DSUVIA and is included in one NDA.

This patent has seventy-four patent family members in twelve countries.

Summary for Patent: 8,778,394
Title:Small-volume oral transmucosal dosage forms
Abstract: Small-volume oral transmucosal dosage forms or NanoTabs.RTM. comprising a predetermined amount of a pharmaceutically active drug are provided. Exemplary applications include use of the NanoTabs.RTM. to administer a drug for the treatment of acute, post-operative or breakthrough pain.
Inventor(s): Palmer; Pamela (San Francisco, CA), Schreck; Thomas (Portola Valley, CA), Tzannis; Stelios (Petaluma, CA), Hamel; Larry (Pacific Grove, CA), Poutiatine; Andrew I. (Mill Valley, CA)
Assignee: AcelRx Pharmaceuticals, Inc. (Redwood City, CA)
Application Number:13/561,543
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation; Delivery; Device; Dosage form;
Patent landscape, scope, and claims:

Understanding the Scope and Claims of United States Patent 8,778,394: A Comprehensive Analysis

Introduction to Patent Law and the USPTO

The United States Patent and Trademark Office (USPTO) is the central agency responsible for granting U.S. patents and registering trademarks. Understanding the nuances of patent law is crucial for navigating the complex landscape of intellectual property protection[5].

Overview of United States Patent 8,778,394

To delve into the specifics of United States Patent 8,778,394, it is essential to start with the basics:

  • Patent Title and Abstract: The title and abstract provide a preliminary understanding of the invention's nature and scope.
  • Background of the Invention: This section explains the context and prior art related to the invention.
  • Summary of the Invention: A concise description of the invention, its components, and how it works.

Patent Claims: The Heart of the Patent

Independent and Dependent Claims

Patent claims are the legal boundaries that define the invention. They are categorized into independent and dependent claims. Independent claims stand alone and define the invention, while dependent claims refer back to and further limit the independent claims[1].

Claim Scope and Breadth

The scope of patent claims is a critical aspect of patent quality. Metrics such as independent claim length and independent claim count can be used to measure patent scope. Broader claims can lead to increased licensing and litigation costs, while narrower claims are often associated with a higher probability of grant and a shorter examination process[3].

Patent Eligibility and Validity

Proving Patent Eligibility

For a patent to be valid, it must meet the criteria of patent eligibility under the patent statutes. This includes being a new and useful process, machine, manufacture, or composition of matter, or any improvement thereof[1].

Obviousness-Type Double Patenting (ODP)

ODP is a doctrine that prevents patentees from obtaining a second patent on a patentably indistinct invention to effectively extend the life of a first patent. Recent court decisions, such as the Federal Circuit's ruling in Allergan USA, Inc. v. MSN Laboratories Private Ltd., have clarified that a first-filed, first-issued, later-expiring patent claim cannot be invalidated for ODP by a later-filed, later-issued, earlier-expiring reference patent claim having a common priority date[2].

Patent Term Adjustment (PTA) and Its Impact

Understanding PTA

PTA is a mechanism to adjust the term of a patent to account for delays during the prosecution process. This adjustment can affect the expiration date of the patent and is crucial in ODP analyses[4].

ODP Analysis with PTA

In cases involving PTA, the relevant expiration date for ODP analysis is the adjusted expiration date, including any PTA. This was highlighted in the Cellect case, where the Federal Circuit emphasized that ODP analysis must consider the expiration date after PTA is added[4].

Prosecution History and Continuation Applications

Continuation Applications

Patents like U.S. Patent 8,778,394 may arise from continuation applications, which are filed to pursue additional claims related to the original patent application. These applications can share a common priority date but may have different issuance and expiration dates[2].

Impact on Patent Scope

The prosecution history, including any amendments or arguments made during the examination process, can significantly impact the scope of the patent claims. Narrower claims at publication are often associated with a higher probability of grant and a shorter examination process[3].

Litigation and Enforcement

Patent Infringement Suits

Patent holders may file infringement suits to protect their intellectual property. The validity of the patent claims is often a central issue in these suits. Recent cases, such as Allergan USA, Inc. v. MSN Laboratories Private Ltd., demonstrate the complexities involved in defending patent claims against ODP challenges[2].

Role of the Federal Circuit

The Federal Circuit plays a pivotal role in interpreting patent law and resolving disputes. Decisions from this court, such as those in Cellect and Allergan, provide guidance on how to apply doctrines like ODP in various scenarios[2][4].

Industry Impact and Innovation

Patent Quality and Innovation

The quality and scope of patent claims can influence innovation. Overly broad or unclear patents can increase licensing and litigation costs, potentially diminishing incentives for innovation. Conversely, well-defined and narrowly scoped patents can facilitate clearer boundaries and encourage further innovation[3].

Real-World Examples

For instance, in the pharmaceutical industry, patents like those covering ViberziĀ® (eluxadoline tablets) are critical for protecting intellectual property. The legal battles surrounding these patents highlight the importance of precise claim drafting and the nuances of patent law[2].

Key Takeaways

  • Patent Claims: The heart of any patent, defining the legal boundaries of the invention.
  • ODP: Prevents extending patent life through patentably indistinct inventions.
  • PTA: Adjusts patent term for prosecution delays, affecting ODP analyses.
  • Prosecution History: Influences claim scope and validity.
  • Litigation: Central to protecting intellectual property, with the Federal Circuit providing crucial interpretations.
  • Industry Impact: Patent quality affects innovation and licensing costs.

FAQs

What is the purpose of Obviousness-Type Double Patenting (ODP)?

ODP prevents patentees from obtaining a second patent on a patentably indistinct invention to effectively extend the life of a first patent[2].

How does Patent Term Adjustment (PTA) affect ODP analysis?

PTA adjusts the patent term for prosecution delays, and the relevant expiration date for ODP analysis is the adjusted expiration date, including any PTA[4].

What are the key metrics for measuring patent scope?

Independent claim length and independent claim count are simple metrics used to measure patent scope[3].

Why is the prosecution history important for patent claims?

The prosecution history, including amendments and arguments, can significantly impact the scope and validity of patent claims[3].

How do Federal Circuit decisions influence patent law?

Federal Circuit decisions provide authoritative interpretations of patent law, guiding how doctrines like ODP are applied in various scenarios[2][4].

Sources

  1. BitLaw: Patent Law in the United States - BitLaw.
  2. Whitecase: Federal Circuit Limits the Application of Obviousness-Type Double Patenting for Patents in the Same Family.
  3. SSRN: Patent Claims and Patent Scope.
  4. Federal Circuit: In re Cellect - United States Court of Appeals for the Federal Circuit.
  5. USAGov: U.S. Patent and Trademark Office (USPTO).

More… ↓

⤷  Subscribe


Drugs Protected by US Patent 8,778,394

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Vertical Pharms DSUVIA sufentanil citrate TABLET;SUBLINGUAL 209128-001 Nov 2, 2018 RX Yes Yes 8,778,394 ⤷  Subscribe TREATMENT OF ACUTE PAIN ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 8,778,394

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 2114383 ⤷  Subscribe 300797 Netherlands ⤷  Subscribe
European Patent Office 2114383 ⤷  Subscribe CA 2016 00007 Denmark ⤷  Subscribe
European Patent Office 2114383 ⤷  Subscribe CR 2016 00007 Denmark ⤷  Subscribe
European Patent Office 2114383 ⤷  Subscribe 122016000023 Germany ⤷  Subscribe
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.